MAUDE Adverse Event Report: ZIMMER BIOMET EXTRACTOR

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Rheumatoid Arthritis (1724); Failure of Implant (1924); Unspecified Infection (1930); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Wife, (b)(6) had shoulder replacement.Got infection and hardware had to be removed.During surgery the implant puller broke and had to be stitched back up and another surgery scheduled to finish removing hardware.In meantime couldn't be on ra(rheumatoid arthritis) medicine causing high arthritis.Also another surgery.Biomet been looking into it for 3 months now.I recommend another off site facility to investigate.

Event Description

Additional information received on 2/6/2024 for report mw5151077 to update procode.

Event Description

Additional information received on 2/6/2024 for report mw5151077 to change procode to hwb.

• Brand Name: EXTRACTOR
• Type of Device: EXTRACTOR
• Manufacturer (Section D): ZIMMER BIOMET; 1800 w. center st; warsaw IN 46580
• MDR Report Key: 18650278
• MDR Text Key: 334652280
• Report Number: MW5151077
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1